NCT05281718CompletedEarly phase 1
Factor IX as Adjunctive Therapy to Emicizumab (EMIX)
An in Vitro Pilot Study of the Role of Factor IX as an Alternative to Bypassing Agents in the Treatment of Breakthrough Bleeds in Patients With Hemophilia A and Inhibitors Treated With Emicizumab.
Source: ClinicalTrials.gov · Last updated 20 Jan 2025
Brief summary (registry, in English)
This trial will enroll patients with severe hemophilia A. Experiments will be run in vitro by spiking patients' blood with different molecules (currently used and theoretically proposed as adjunctive therapy to emicizumab), therefore no more than minimal direct risk to patients is expected. This is a pilot preclinical study.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 11 Feb 2022
- Start date
- 1 Aug 2022
- Primary completion date
- 7 Mar 2024
- Lead sponsor
- Tulane University
- Diseases
- Haemophilia
- NCT number
- NCT05281718
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 12
- From 1 Aug 2022 to the primary completion date, 7 Mar 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients that have received any hemostatic agent within 5 half-lives of the blood draw. This applies to any agent that might have been used for any reason prior to the blood draw and might affect the global hemostasis.
Other
- Not able to sign consent
- Not willing to provide extra blood for the experiments.
- Patients carrying the diagnoses of other coagulopathies in addition to hemophilia A
Who the study is looking for
- Signed Informed Consent/Assent Form
- Male patients, Age 12 years and older at time of signing Informed Consent Form
- Ability to comply with the study protocol, in the investigator's judgment
- Diagnosis of severe hemophilia A and are receiving emicizumab prophylaxis, on a weekly maintenance regimen
Age in the registry: 12 years to 120 years · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tulane University Lakeside Hospital and Clinics Coordinator of this site? Confirm its status | Metairie | United States | Unknown status |
| University Medical Center New Orleans Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.